We are seeing global progress in the implementation of IDMP. EMA has brought live elements of their SPOR (PMS, OMS, RMS) program and work with input from multiple regulators continues.
Topics
Pharmacovigilance
IDMP
E2B
The transition to E2B (R3) for electronic submission of ICSRs continues. Vendors have rolled out R3-compliant versions of their PV databases. More and more jurisdictions make the new format mandatory, and almost every regulator add local/regional fields with additional rules. So, E2B (R3) compliance continues to be a (slowly?) moving target.
Tools
Downloading information from EudraVigilance is a mandatory activity since 22-Nov-2017. Identifying and selecting what to download and eventually import in their own databases is not a simple task for many authorization holders. Tools are available to help manage these tasks efficiently. Let us help you leverage them.
Managing submissions is a major task in pharmacovigilance. Even without (or to support) a dedicated safety system, specialized tools are available which make the handling and maintenance of dozens or even hundreds of submissions a breeze.
Learning and Learning Management
People are at the center of most controlled and regulated processes. They must be adequately trained, and documentation of such training must be readily available. As part of your quality system, a learning management system or platform helps you with the planning, coordination, execution, success control, and documentation of trainings and other required activities.
Learning, and learning management has been one of the core topics of my professional life for more than 35 years, helping customers to efficiently make knowledge available when and where required.